Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Zhejiang University

Status: Not yet enrolling

Conditions: Helicobacter Pylori Infection

Study type: Observational

Funder types: Other

Identifiers

NCT06037122

2023-0674

Details and patient eligibility

About

The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection.

Full description

Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB) vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ 20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as initial treatment for H. pylori infection. Our study will provide clinical evidence for the necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize the treatment regimen for H. pylori infection.

Enrollment: 558 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture;
2. No previous eradication therapy for H. pylori;
3. Age and gender are not restricted.

Exclusion criteria

1. Use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks prior to treatment;
2. Known hypersensitivity to the drugs used in this study;
3. History of esophageal or gastric surgery;
4. Pregnant or lactating women;
5. Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer);
6. Patients unable to express their main complaints.

Trial design

558 participants in 3 patient groups

group R-BID

Description:

rabeprazole 10mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days

group V-BID

Description:

vonoprazan 20mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days

group V-QD

Description:

vonoprazan 20mg once daily, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days